MSF statement on a donation of TB drugs from Otsuka Pharmaceutical Co., Ltd.

19 February 2016

Wendy Marijnissen

16 year-old-Shahnoza started MDR-TB treatment in October 2012 but was later diagnosed with XDR-TB.

MSF appreciates Otsuka’s donation of 400 treatments of a novel drug, delamanid, which enables MSF and its partners to initially treat a specific number of MDR-TB patients worldwide.

Donations are an exception to MSF policy. They are not a solution to relieving the world’s global TB burden. MSF avoids donations wherever possible and advocates for fair commercial terms on drugs access. Otsuka has not yet announced delamanid’s commercial conditions. Until then, this donation represents a way to offer quick access to delamanid for at least some of the estimated 40,000 patients who need it worldwide.

Only about 100 patients worldwide have been treated with delamanid so far on a compassionate use basis. Many of these patients obtained access to the drug within the remit of MSF’s DR-TB programmes.

Some of these programmes belong to the “Expand New Drug Markets for Tuberculosis” (‘endTB’) project, a partnership between MSF, Partners in Health (PIH), Interactive Research and Development (IRD) and their financial partner, UNITAID.

“In recent years we have provided delamanid to a restricted number of patients with no therapeutic options left”, Dr. Francis Varaine, leader of MSF’s international working group for TB and endTB project leader, explains.

“This donation will allow us to treat more patients with delamanid earlier in their illness,” Dr. Varaine adds. As part of the endTB project, a larger cohort of patients worldwide will receive delamanid treatment as part of an operational treatment study. Other partners involved in the endTB project, namely PIH and IRD, will administer delamanid from this donation. Other DR-TB programmes run by MSF will also access delamanid from the donation.

The project will observe World Health Organization (WHO) guidelines for the use of delamanid, which has yet to complete its clinical development process.

“We will continue to advocate for quick and wide access to delamanid, to provide more effective treatments against DR-TB in the future,” Dr. Varaine adds. “It is essential to put the needs of patients first. This means boosting these new drugs’ uptake in countries with high TB burdens, where access remains a major issue.”

About the end TB partnership

endTB (expand new drug markets for TB) aims to find shorter, less toxic & more effective treatments for MDR-TB, using the first two drugs developed in 50 years: bedaquiline and delamanid.

Enrollment of a minimum of 2,600 MDR-TB patients who will receive new TB drugs (bedaquiline or delamanid) will take place in 15 countries: Armenia, Bangladesh, Belarus, Democratic People's Republic of Korea, Ethiopia, Georgia, Kazakhstan, Kenya, Kyrgyzstan, Indonesia, Lesotho, Myanmar, Nepal, Pakistan and Peru. Each patient will be monitored closely for response to treatment and for potential adverse events.

Clinical trials will take place in five sites (Georgia, Kazakhstan, Kyrgyzstan, Lesotho, Peru) and will study the safety and efficacy of several 'user-friendly' MDR-TB treatment regimens, each containing one new drug or both.

The project will also reduce existing country-level barriers to the uptake of new TB drugs. It will provide evidence to facilitate their registration in countries, advocate for simple and swift procurement mechanisms. Moreover, the project will build a broader evidence-base for WHO recommendations for the use of new TB drugs.

The four-year project is funded by a UNITAID grant of up to 60,4 million US$.